Nico Corp. recalls Myriad-LX Light Sources with serial numbers 350-00194D to 350-00475D due to potential tissue damage from sleeve occlusion during surgery. Updated instructions prevent light output reduction and sleeve blockage.
(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.
Nico Corp. is recalling Myriad-LX Light Sources with specific serial numbers because improper use could cause the light delivery sleeve to block, reducing light output and potentially damaging tissue. This risk is most concerning during certain surgical procedures like endonasal approaches.
The light delivery sleeve can become blocked by tissue or debris, reducing light output and potentially causing tissue damage. This risk is higher during certain surgical techniques where the sleeve is more likely to come into contact with tissue.
Surgical teams using the Myriad-LX Light Source for procedures like endonasal surgery are most at risk. Patients and medical staff who have the recalled serial numbers should check their devices.
Check the serial number on the Myriad-LX Light Source, which ranges from 350-00194D to 350-00475D. The device is a high-intensity surgical light used for tissue visualization during resection procedures.
Identify the serial number on the device, which should be between 350-00194D and 350-00475D.
If the sleeve appears blocked or light output is reduced, replace both the delivery sleeve and fiber immediately.
The delivery sleeve can become blocked by tissue or debris, reducing light output and potentially causing tissue damage during surgery.
Serial numbers from 350-00194D to 350-00475D (specific ranges listed in the recall).
Yes, if the sleeve is blocked or light output is reduced, replace both the delivery sleeve and fiber immediately.
We’ve drafted a message you can send Nico Corp. to request your refund or repair — edit it as you like.
Subject: Recall Z-1840-2021 — Nico Corp. Nico Corp. Hello, I own a Nico Corp. that is covered by recall Z-1840-2021 from Nico Corp.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
